Study to Evaluate the Efficacy and Safety of Risperidone ISM® in Patients With Acute Schizophrenia: Open Label Extension

NCT03870880 | Completed Phase 3 Results FDA Drug

• 1 other identifier: ROV-RISP-2016-01_OLE
• Study Type: interventional
• Target: 215
• Locations: 2 countries
• Sites: 24

Brief Summary

This is the long-term open label extension (OLE) of the study PRISMA-3 (NCT03160521). Those patients who complete participation in the main segment of the study (double blind) together with other clinically stable not previously enrolled (de novo patients) may opt to participate in this extension segment, where they will receive active Risperidone ISM® (75 mg or 100 mg)under open-label conditions every four weeks for approximately 12 months.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• PANSS Total Score Mean Change From Baseline to Endpoint

  The Positive and Negative Syndrome Scale (PANSS) is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia.The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score is the sum of all 30 PANSS items and ranges from 30 to 210, with 30 indicating absence of symptoms of schizophrenia and 210 indicating extreme ratings of all 30 symptoms. Negative change from baseline scores indicates improvements in symptoms whereas higher scores mean a worse outcome. Endpoint is defined as study day 365 or the last post-baseline assessment if early discontinuation.

  Baseline and Day 365 (or the last post-baseline assessment)

Other Outcomes (10)

• PANSS Positive Subscale Mean Change From Baseline to Endpoint

  Baseline and Day 365 (or the last post-baseline assessment)

• PANSS Negative Subscale Mean Change From Baseline to Endpoint

  Baseline and Day 365 (or the last post-baseline assessment)

• PANSS General Psychopathology Subscale Mean Change From Baseline to Endpoint

  Baseline and Day 365 (or the last post-baseline assessment)

Study Arms (2)

Risperidone ISM 75 mg

EXPERIMENTAL

Patients assigned to this arm will receive 75 mg of Risperidone ISM during the open label extensión (OLE). Patients enter the study as rollover patients from the study NCT03160521, along with newly enrolled de novo patients.

Drug: Risperidone ISM 75 mg

Risperidone ISM 100 mg

EXPERIMENTAL

Patients assigned to this arm will receive 100 mg of Risperidone ISM during the open label extensión (OLE). Patients enter the study as rollover patients from the study NCT03160521, along with newly enrolled de novo patients.

Drug: Risperidone ISM 100 mg

Interventions

Risperidone ISM 75 mg DRUG

Monthly (once every 4 weeks) intramuscular (IM) injection in the gluteal or deltoid muscle.

Risperidone ISM 75 mg

Risperidone ISM 100 mg DRUG

Monthly (once every 4 weeks) IM injection in the gluteal or deltoid muscle.

Risperidone ISM 100 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be eligible for entry into the extension segment of the study PRISMA-3, a patient must meet all of the following criteria at the extension baseline time point (immediately upon completion of the end-of-treatment visit assessments and procedures for the main part of the study):
• Has completed scheduled participation in the double blind segment of the study PRISMA-3, through to the end of the treatment period and including the end-of-treatment visit
• Continues to require long-term treatment with an antipsychotic medication, in the opinion of the investigator
• Continues to meet contraceptive requirements of the study PRISMA-3
• Is willing to participate in the extension segment of the study and remains capable of providing informed consent
• a. A signed informed consent form must be provided before any study assessments are performed for the extension segment
• Continues to reside in a stable living situation, in the opinion of the investigator
• Continues to have an identified reliable informant, in the opinion of the investigator

You may not qualify if:

• An individual who meets any of the following criteria at the extension baseline time point (immediately upon completion of the end-of-treatment visit assessments and procedures for the double blind segment PRISMA-3) will not be permitted to enter into this extension segment of the study PRISMA-3:
• Missed more than 1 scheduled study visit during participation in the double blind segment of study PRISMA-3
• Had an abnormal clinical laboratory value, vital sign, or ECG finding during participation in the main part of the study that, in the opinion of the investigator, was clinically relevant, related to study drug, and would compromise the well-being of the patient in the extension segment
• Had a clinically significant or unstable medical illness/condition/disorder during the main part of the study that would be anticipated, in the investigator's opinion, to potentially compromise patient safety in the extension segment
• Is taking or is anticipated to require any prohibited concomitant medication
• Pregnant, lactating, or breastfeeding
• Any contraindication for continued IM injections (e.g., treatment with anticoagulant)
• Inadequate gluteal or deltoid musculature or excessive fat, as determined by the investigator, that would interfere with IM study drug injections
• Study site personnel and/or persons employed by the investigator or study site or is an immediate family member of such persons
• Capable of providing informed consent
• Age ≥ 18 and ≤ 65 years old
• On a stable dose of oral risperidone from 4 to 6 mg daily as maintenance therapy for at least the last 4 weeks prior/before screening/baseline and would potentially benefit from conversion to an extended release injectable, in the opinion of the investigator
• Current diagnosis of schizophrenia, according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria that is clinically stable as evidenced by:
• No hospitalizations for acute exacerbations of schizophrenia and psychiatrically stable without significant symptom exacerbation over the last 3 months before screening based on the investigator's judgment
• PANSS total score \< 70 at screening

Sponsors & Collaborators

• Rovi Pharmaceuticals Laboratories: lead

Study Sites (24)

Woodland Research Northwest

Rogers, Arkansas, 72758, United States

Location

Collaborative Neuroscience Network, LLC.

Garden Grove, California, 92845, United States

Location

Apostle Clinical Trials Inc.

Long Beach, California, 90813, United States

Location

NRC Research Institute

Orange, California, 92868, United States

Location

CNRI-Los Angeles LLC

Pico Rivera, California, 90660, United States

Location

CNRI-San Diego

San Diego, California, 92112, United States

Location

Galiz Research

Hialeah, Florida, 33016, United States

Location

Innovative Clinical Research Inc.

Hollywood, Florida, 33021, United States

Location

CBH Health LLC

Gaithersburg, Maryland, 20877, United States

Location

Altea Research Institute

Las Vegas, Nevada, 89102, United States

Location

Hassman Research Institute

Berlin, New Jersey, 08009, United States

Location

Midwest Clinical Research Center

Dayton, Ohio, 45417, United States

Location

InSite Clinical Research

DeSoto, Texas, 75115, United States

Location

Regional Clinical Hospital n.a I.I. Mechnicov

Dnipro, 49005, Ukraine

Location

Kharkiv Regional Clinical Psychiatric Hospital

Kharkiv, 61068, Ukraine

Location

Public Healthcare Institution "Kharkiv Regional Clinical Psychiatric Hospital No. 3", Center of Urgent Psychiatry

Kharkiv, 61068, Ukraine

Location

Kherson Regional Psychiatric Hospital

Kherson, 73488, Ukraine

Location

Kiev City Psychiatric Hospital No. 2

Kiev, 02192, Ukraine

Location

Kyiv Regional Medical Association "Psykhiatriya" in Kyiv

Kiev, 04080, Ukraine

Location

CI Lviv Regional Clinical Psychiatric Hospital. Department 20

Lviv, 79021, Ukraine

Location

CI Lviv Regional Clinical Psychiatric Hospital. Department 25

Lviv, 79021, Ukraine

Location

Odesa Regional Medical Centre of Mental Health

Odesa, 65006, Ukraine

Location

Maltsev Regional Clinical Psychiatric Ho

Poltava, 36013, Ukraine

Location

N.I. Pyrogov Vinnytsya Natl Medical University

Vinnytsia, 21005, Ukraine

Location

Related Publications (1)

• Filts Y, Litman RE, Martinez J, Anta L, Naber D, Correll CU. Long-term efficacy and safety of once-monthly Risperidone ISM(R) in the treatment of schizophrenia: Results from a 12-month open-label extension study. Schizophr Res. 2022 Jan;239:83-91. doi: 10.1016/j.schres.2021.11.030. Epub 2021 Nov 27.

  PMID: 34847501 RESULT

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Director of Medical Department
• Organization: Laboratorios Farmacéuticos Rovi, S.A.

departamento.medico@rovi.es

91 375 62 30

Study Officials

• Robert Litman

  CBH Health LLC

  PRINCIPAL INVESTIGATOR

• Yuriy Filts

  CI Lviv Regional Clinical Psychiatric Hospital. Department 25

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: It is an open label extension
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2019
• First Posted: March 12, 2019
• Study Start: August 25, 2017
• Primary Completion: January 8, 2020
• Study Completion: January 8, 2020
• Last Updated: March 25, 2022
• Results First Posted: February 23, 2022

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (13); UA (11)